- Published: September 20, 2021
ART MEDICAL is a well-funded, medical startup developing cutting-edge technologies for ICU patients. Our smART+™ platform is an intelligent, sensor-based feeding system for critical care patients that aims to prevent life-threatening in-hospital complications such as ventilator-associated pneumonia, malnutrition, and acute kidney injury. With the introduction of Nutrition Management 2.0™ to critical care patient scoring systems, the smART+™ platform monitors analyze, and prevents malnutrition and gastric aspiration in real-time. By providing optimal nutritional care and achieving up to 100% feeding efficiency, the smART+™ platform improves the standard of care and helps ICU patients recover faster.
- Regulatory responsibilities associated with the development, support, and manufacturing of the Company’s medical device products (including compliance).
- Supervise and manage Regulatory Affairs tasks: managing day-to-day workload and operational issues.
- Provide training, coaching, support, and acting as a point of escalation where necessary for Regulatory Affairs Specialists.
- Responsibility for implementing regulatory requirements for post-market surveillance and clinical in accordance with ISO13485, EU MDR 2017/745 and other jurisdictions as required.
- Preparation / Review of responses to global regulators in relation to Post Market Surveillance, Post-Market Clinical Follow-Up, Clinical Evaluation, Summaries of Safety and Clinical Performance.
- Ensure Post Market Surveillance and Clinical Evaluation are conducted to schedule.
- Initiate regulatory documentation and ensure they completion for pre-market products, as per the design control process and procedures.
- Ensure global requirements are met and relevant regulatory guidance documents identified.
- Participate in internal and external audits as Subject Matter Expert in Post Market Surveillance and Clinical
- Actively pursues ways in which to improve the function of the Regulatory Affairs Department supporting continuous improvement activities.
- Identify and interpret relevant regulatory guidelines.
- Minimum of 5 years experience in regulatory affairs in the Medical Device industry
- must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.
- Scientific, medical, or technical background or relevant industry experience
- Excellent English
- Excellent problem-solving, judgment, and decision-making skills
- Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.